Generic drugmakers get revised MAPP for suitability petitions

FDA’s Office of Generic Drugs released an updated Manual of Policies and Procedures (MAPP), which guides how applicants can petition FDA to submit an abbreviated new drug application (ANDA). Pharmaceutical companies submit ANDAs if a generic drug differs from a reference listed drug (RLD) in dosage form or strength, or in its route of administration, as per Section 505(j)(2)(C) of the Federal Food, Drug, & Cosmetic Act. That legislation also applies to situations when a drugmaker seeks to submit an ANDA for a fixed-combination drug that has a single active ingredient that differs from the RLD. The MAPP states that FDA will approve a suitability petition under these criteria unless one of three circumstances is present: FDA cannot adequately evaluate the safety and effectiveness of the proposed generic without the conduct of investigations that are beyond the scope of an ANDA; a drug product is approved in a new drug application for the same change that is requested in the petition; or the change would trigger pediatric studies as required under the Pediatric Research Equity Act. Furthermore, the MAPP states that FDA will not receive an ANDA “citing to a pending suitability petition (or to a suitability petition that was denied) because that ANDA would lack a legal basis for submission.”